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The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients

The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03213860
Enrollment
80
Registered
2017-07-11
Start date
2017-07-15
Completion date
2017-09-29
Last updated
2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Sleep Deprivation

Brief summary

Environmental factors such as noise and light have been cited as important causes of sleep deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol. Another studies indicated that using eye masks can improve REM sleep in healthy subjects in simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to determine the effects of using eye masks on sleep and thus on pain quality in postoperative cardiac surgery patients in ICU.

Interventions

OTHERFlight Eye-masks; Dreaming, Zhuji City, Zhejiang, China

The experimental group will receive protective devices Single use eye masks during nocturnal sleep (Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China). The caregiver will explain to them that they should wear eye masks during their stay in ICU to ensure rest and instructed patients to use them properly. During the ICU stay, ICU nurses will assist patients with wearing eye masks from 9:00 pm to 7:00 am the next morning.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

While it is not possible to blind participants and clinical staff to the assigned interventions, the assessments will be undertaken by a researcher blinded to group allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (1) age ≧18 years; (2) no history of neurological or psychiatric disorders; (3) ability of patients to communicate verbally and understand the sleep questionnaires administered in the ICU; (3) length of ICU stay ≥48 hours; (4) Glasgow coma score (GCS) \>8 in the first to third day. Postoperative Extubation of MV within few hour (before the time of 9 pm for postoperative patients.

Exclusion criteria

* Patients over age 65 were excluded from the study because of potential age-related differences in sleep. Patients reporting frequent nighttime awakenings, snoring, or chronic use of benzodiazepines or opioids were excluded because of potential confounding influences of these factors on postoperative sleep, pain, or opioid requirement.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain3 postoperative daysvisual analogue scale will be used. ranging from 0 mm (no pain) to 100 mm (worst pain imaginable).

Secondary

MeasureTime frameDescription
Quality of sleep3 postoperative daysthe Arabic version of the Richards-Campbell Sleep Questionnaire (RCSQ)The five-point RCSQ was designed to evaluate different aspects of night-time sleep, including: (1) depth; (2) latency (time to fall asleep); (3) number of awakenings; (4) efficiency (percent of time awake), and (5) quality. Each item was scored using a 100-mm visual-analogue scale (VAS), which ranged from 0 mm (worst sleep) to 100 mm (optimal sleep). Total score was calculated by dividing the sum of all scores by five. The RCSQ was administered by the researcher daily, at 7:00am every morning.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026